Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia

NCT02873091 | Unknown DMC

• 1 other identifier: NJFY2016002
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

Sixteen million babies were born in 2010, approximately half were by cesarean. Labor analgesia should be the first choice for these parturients based on the consideration of security and humanization. However this labor analgesia rate is quite low in China (\<5%) while in western country, this rate is up to 60%. Programmed intermittent epidural bolus (PIEB) is the latest technique for labor analgesia which has less neurotoxicity theoretically compared with Continuous Epidural Infusion(CEI) with Patient controlled epidural analgesia (PCEA) which is used most commonly. In that study, they reported less total local anesthetic consumption, fewer manual bolus doses and greater patient satisfaction with the PIEB technique. In China, multiple factors contribute to the reasons of low labor analgesia rate. From the patient's point of view, worrying about unsatisfied analgesia, and not adapted to the symptoms of motor block, such as inability to move their legs distressing, both are important reasons of refusing labor analgesia and preferring to cesarean delivery. Therefore, in this clinical trial, we plan to find a safer and more effective regimen for labor analgesia in Chineseparturients. This clinical trial is designed to prove PIEB used Ropivacaine is safer and more effective than CEI for labor analgesia in Chinese parturients.

Conditions

Labor Analgesia

Outcome Measures

Primary Outcomes (1)

• Maternal visual analogue scale (VAS)

  a visual analog scale (VAS) with a 10 cm vertical score ranged from "no pain" to "worst possible pain"

  At time of initiation of analgesia and hourly thereafter until 1 hours postpartum (approximately 10 hours)

Secondary Outcomes (17)

• Maternal modified Bromage scale

  At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)

• Subject's Satisfaction with labor epidural analgesia

  At the time after childbirth

• Total ropivacaine and sufentanil consumption

  At two hours postpartum

• Proportion of parturients requiring additional PCEA boluses

  At two hours postpartum

• Rate of "very satisfied"and/or "satisfied",Proportion of subjects who has experienced Visual analog scale (VAS) score for pain more than 3 scale

  At two hours postpartum

Study Arms (3)

CEI

ACTIVE COMPARATOR

Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of CEI: 10 ml/h, beginning immediately after the initial dose

Procedure: Epidural analgesia; Procedure: Continuous epidural infusion; Drug: ropivacaine; Drug: sufentanil

PIEB 1

ACTIVE COMPARATOR

Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil.The basal infusion of PIEB1: 5 ml per 30 min, beginning 30 min after the initial dose

Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus; Drug: ropivacaine; Drug: sufentanil

PIEB 2

ACTIVE COMPARATOR

Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of PIEB2: 10 ml per 60 min, beginning 60 min after the initial dose

Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus; Drug: ropivacaine; Drug: sufentanil

Interventions

Epidural analgesia PROCEDURE

CEI; PIEB 1; PIEB 2

Continuous epidural infusion PROCEDURE

CEI

Intermittent epidural bolus PROCEDURE

PIEB 1; PIEB 2

ropivacaine DRUG

CEI; PIEB 1; PIEB 2

sufentanil DRUG

CEI; PIEB 1; PIEB 2

Eligibility Criteria

• Age: 22 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who agree to join this study
• Age: 22y-40y
• American Society of Anesthesiologists (ASA) physical status 1 or 2
• Gestation : 37-41 weeks
• Primipara
• Singleton fetus and head presentation
• In early labor: cervical dilation for 1-3cm
• Requesting labor epidural analgesia

You may not qualify if:

• Contraindication for epidural analgesia
• Height less than 150 cm or more than 170 cm
• Morbid obesity (BMI more than 35)
• High-risk pregnancy:(gestational diabetes mellitus, gestational hypertension, placenta previa, placental abruption, preeclampsia)
• Received parenteral opioids
• Unable to perform motor block evaluation tests

Sponsors & Collaborators

• Nanjing Maternity and Child Health Care Hospital: lead

Study Sites (1)

Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, 210004, China

RECRUITING

MeSH Terms

Interventions

Analgesia, Epidural; Ropivacaine; Sufentanil

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Caijuan Li, M.A.

CONTACT

025-52226112; licaijuanyumi1228@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nanjing Maternity and Child Health Care Hospital

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 19, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 28, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)